Calibration Technician III

Position Summary:

• The calibration technician works within a team environment that actively supports, participates, and embraces an empowered team culture including significant interaction with Quality Assurance, Manufacturing Operations, Engineering, and other support groups.
• Perform Calibration to instrumentation that includes but is not limited to Temperature, Relative Humidity (RH), Timers, RPM, Flow (liquid), Pressure, Load Cell Weight Indicators, Balances, and measurement Standards within a GMP manufacturing. environment while performing work in a controlled clean room environment(s).
• Knowledgeable of National Institute of Standards Technology (NIST) or equivalent and Secondary Standard Laboratories
• Must be able to evaluate instrument and equipment performance, complete calculations, perform Reverse Traceability Reports, and initiate Deviations as they pertain to instrumentation and equipment
• Support calibration and instrumentation for NPI's (New Product Introduction), which includes but is not limited to evaluation of current and future instruments and their range(s) / tolerance(s) to meet process requirements
• Support various groups with the resolution of Deviations and CAPA's as required.
• The technician will be required to follow, revise, and assist in the development of Standard Operating Procedures (SOP's), Training Modules (TRN), and Technical Documents (TD) for calibration
• Assist with execution of Corrective Preventive Action (CAPA) plans
• Must be able to provide "On-Call" response to support plant operations during off-hours as required
• Adhere to all safety requirements and follow all safety procedures
• Off hours coverage may be requested, which can include nights and weekends.

Position Description:

• Provide day to day Calibration and Maintenance/Utility functions including but is not limited to:
• Perform calibration to process equipment and instrumentation as required by established guidelines and Standard Operating Procedures (SOP's), Training Modules (TRN), and Technical Documents (TD).
• Ability to conduct troubleshooting by use of equipment manuals and drawings, identifying root cause, and assist in determining appropriate corrective actions for equipment failures. Generate and assist with resolving Deviations, CAPA's to instrument and equipment.
• Assist and troubleshoot with maintenance personnel with general facility repairs not to exclude lighting, walls, floors, windows as well as troubleshoot equipment and systems, including mechanical, electrical, pneumatic, or hydraulic circuits (motors, pumps, compressors, boilers, chillers, and purified and domestic water systems)
• Create, and update equipment/instrumentation within Computer Maintenance Management System (CMMS)
• Make recommendations and revise required Standard Operating Procedures (SOP), Training Modules (TRN), and Technical Documents (TD) for process equipment/instrumentation and support utilities
• Train Calibration Technicians on effective SOP's, TRN's, and TD's
• Provide "on-call" response to support plant operations during off-hours as required
• Adhere to all safety requirements and follow safe procedures, immediately notifying management or HSE when unsafe conditions or potential hazards exist. Attend all required safety and health training, including handling of hazardous and non-hazardous waste, when necessary

Position Requirements:

• High School diploma and a two-year degree in Engineering, Life Sciences, other related technical field or equivalent military training and 5-9 years of applicable (Metrology, Instrumentation, Calibration) experience or the equivalent combination of education and experience.
• Prior experience in a cGMP pharmaceutical manufacturing environment
• Strong understanding of Standard Operating Procedures, Corrective Preventive Actions, and Deviations
• Understand 4-20 mA loops, low voltage, 120 VAC/DC
• Knowledgeable of National Institute of Standards Technology (NIST) and/or equivalent
• Familiar with USP 41 requirements
• Familiar working within Computerized Maintenance Management System to schedule and document work performed
• Knowledge of general OSHA safety requirements and plus
• Must be able to read P&ID's and electrical schematics
• Must be able to use Word, Excel, and Outlook
• Must be able to communicate effectively with colleagues and internal customers and all levels of management.
• minimum of 5 years of manufacturing calibration/instrumentation experience
• Proven knowledge of cGMP manufacturing processes and related codes and regulations
• Knowledge of general OSHA safety requirements
• Experience with Blue Mountain Ram Regulatory Asset Manager operating system
• Experience with calibration methods

Working Conditions
Clean Room Environments
Hours of Work: 10-hour Shift 7:00 am - 5:30pm / Sunday - Wednesday
Salary Range: $31.61 - $43.46 per hour
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.